Evaluation of Plant-based Nutritional Products on Stem Cells

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2020-02-02

Brief Summary

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The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design.

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Detailed Description

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The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design. The research involves testing of acute effects of single doses of antioxidant-rich berry-based extracts, compared to a placebo. Blood samples are taken at baseline and 1 and 2 hours after consuming a single dose. The blood will be used to measure the numbers of different types of stem cells, to evaluate potential effects of stem cell mobilization and homing after consuming plant-based extracts. Adult stem cells are a type of cells that play a role in repairing and rejuvenating various tissue and organs in the body. At NIS Labs, we have shown that many types of plant-based nutritional products have small but reproducible and significant effects on stem cells, cytokines, and regenerative growth factors.

Conditions

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Stem Cell Mobilization Hematopoietic Stem Cell Mobilization Stem Cell Homing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study uses a randomized double-blinded placebo-controlled cross-over study design.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Both the study participants and the research staff interacting with study participants will be blinded to the plant based extract versus placebo.

Study Groups

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Berry extract I

Plant-based antioxidant-rich berry-based extract.

Group Type EXPERIMENTAL

Berry extract I

Intervention Type OTHER

Seabuckthorn berry proanthocyanidin extract 250 mg single dose

Berry extract II

Plant-based antioxidant-rich berry-based extract.

Group Type EXPERIMENTAL

Berry Extract II

Intervention Type OTHER

Seabuckthorn berry proanthocyanidin extract 500 mg single dose

Berry extract blend

Blend of plant-based antioxidant-rich berry-based extracts.

Group Type EXPERIMENTAL

Berry extract blend

Intervention Type OTHER

Seabuckthorn berry blend with other berry-based antioxidants

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Berry extract I

Seabuckthorn berry proanthocyanidin extract 250 mg single dose

Intervention Type OTHER

Berry Extract II

Seabuckthorn berry proanthocyanidin extract 500 mg single dose

Intervention Type OTHER

Berry extract blend

Seabuckthorn berry blend with other berry-based antioxidants

Intervention Type OTHER

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy adults 20-75 years of age;
* Body weight higher than 110 pounds;
* BMI below 35;

Exclusion Criteria

* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem);
* Currently taking daily OTC medications, such as NSAIDs, Tylenol, allergy medications, and others (birth control and 81 mg aspirin not a problem);
* Taking medications that affect the mind (such as anti-depressants) or nervous system (such as gabapentin);
* Currently experiencing intense stressful events and life changes;
* Actively depressed;
* Experiencing sleep disturbances;
* Working night shift;
* Pregnant, nursing, or trying to become pregnant;
* Food intolerances or allergies currently causing discomfort (such as Celiac's disease), due to ongoing inflammatory reactions that may negatively affect product absorption within the 3 hours of testing;
* Food allergies related to ingredients in test product.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes